Vaccine Therapy in Treating Patients With Stage IV or Relapsed Malignant Melanoma
Melanoma

About this trial
This is an interventional treatment trial for Melanoma focused on measuring stage IV melanoma, recurrent melanoma
Eligibility Criteria
Inclusion Criteria: Adults over the age of 18 with malignant melanoma. HLA-A2.1 positive and express MART-1, as assessed by either RT-PCR or by immunohistochemistry Tumor stages T3N0M0 or greater are eligible for this trial according to the following: I (<.75 to 1.5 mm or Clark level III-T1-2N0M0-)-not eligible II (1.5 to 4 mm or level IV-T3N0M0-)-eligible III (limited nodal metastasis involving one regional lymph node basin, or fewer than 5 in-transit metastasis -TxN1M0-)-eligible IV (advanced regional metastasis -TxN2M0- or any distant metastasis -TxNxM1-)-eligible Relapsed melanoma-eligible Patients previously treated with any form of therapy for either metastatic, relapsed or primary melanoma are eligible for this trial, provided that previous treatment was completed >30 days prior to enrollment Both male and females may be enrolled. Premenopausal females must have a negative pregnancy test prior to treatment Karnofsky Performance Status greater than or equal to 70 percent No previous evidence of class 3 or greater New York Heart Association cardiac insufficiency or coronary artery disease No previous evidence of opportunistic infection A minimum of 30 days must have elapsed since the completion of prior chemotherapy, immunotherapy or radiation therapy Adequate baseline hematological function as assessed by the following laboratory values within 30 days prior to study entry (day -30 to 0): Hemoglobin >9.0 g/dl Platelets > 100000/mm3 WBC > 3000/mm3 Absolute Neutrophil Count > 1000/mm3 Positive skin test to common antigens (tetanus and candida) Ability to give informed consent Exclusion Criteria: Lactating females and females of child-bearing potential must have negative serum beta-HCG pregnancy test Acute infection: any acute viral, bacterial, or fungal infection which requires specific therapy. Acute therapy must have been completed within 14 days of prior to study treatment HIV-infected patients Acute medical problems such as ischemic heart or lung disease that may be considered an unacceptable anesthetic or operative risk Patients with any underlying conditions which would contraindicate therapy with study treatment (or allergies to reagents used in this study) Patients with organ allografts Uncontrolled CNS metastasis. Patients with CNS metastasis will be eligible if they have received CNS irradiation to control local tumor growth
Sites / Locations
- Jonsson Comprehensive Cancer Center, UCLA
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Group A
Group B
Group C
Group D
Group E
Group F
No. DC: 10^5 Route of Immunization: ID
No. DC: 10^5 Route of Immunization: IV
No. DC: 10^6 Route of Immunization: ID
No. DC: 10^6 Route of Immunization: IV
No. DC: 10^7 Route of Immunization: ID
No. DC: 10^7 Route of Immunization: IV